BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" CLAVE EXT. SET

    MDR report key: 4914842 · Received July 13, 2015

    Report

    Report Number
    2025816-2015-00076
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATIONS CONT: DIMENSIONAL ANALYSIS OF THE RETURNED 3-WAY STOPCOCK RECORDED THE MALE LUER ID MEASURED 3.12 AND WAS INCOMPATIBLE WITH THE SETS Y-CLAVE CONNECTOR. ALTHOUGH NOT ALWAYS REPEATABLE PREVIOUS ENGINEERING ANALYSIS OF SILICONE PLUG PROTRUSIONS HAVE IDENTIFIED COMPONENT DAMAGES, PERFORMANCE ISSUES CAN OCCUR IF THE CONNECTOR IS ACCESSED/MATED WITH AN INCOMPATIBLE MATING DEVICE. AS STATED ON THE DIRECTIONS FOR USE (DFU) THE CONNECTOR SHOULD ONLY BE ACCESSED WITH AN ISO COMPLIANT MALE LUER WITH AN INSIDE DIAMETER BETWEEN 1.55MM AND 2.8MM. A REVIEW OF THE MFG. LOT DATABASE FOR THE REPORTED LOT# 2975249 (MFG. 12/2014) SHOWED 1100 UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: BASED ON THE ENGINEERING EVALUATION THE REPORTED PRODUCT ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE PROBLEM IS ATTRIBUTABLE TO USE OF INCOMPATIBLE (ID) WHICH CAN RESTRICT/OCCLUDE THE FLUID PATH.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED REPORTING COMPONENT (PLUG PROTRUSION) ISSUE WITH USE OF 011-MC33564 EXT SET. THE INITIAL INFORMATION DESCRIBES THE EVENT AS FOLLOWS: "...ANESTHETIST WAS USING THE SET 011-MC33564 17" EXT SET CLAVE CLEAR CLAMP ROTATING LUER 3 WAY STOPCOCK ATTACHED AND NOTICED THAT THE IV FLUIDS WERE NOT INFUSING VIA THE IV LINE. ON INSPECTION HE NOTICED THE SILICONE FROM INSIDE THE CLAVE CLEAR HAD COME AWAY...OVER THE SEPTUM...APPEARED TO STOP THE FLOW. THE CONSULTANT ANESTHETIST NOTICED THIS QUITE QUICKLY AND CHANGED IT FOR ANOTHER 011-MC33564 EXT. LINE WHICH WORKED WITH NO OTHER PROBLEMS ENCOUNTERED". THERE WERE NO REPORTED PT. INJURIES/ADVERSE OUTCOMES. DEVICE RETURN: ONE USED 011-MC33564 SET; ONE 3-WAY STOPCOCK MFGER.; MODEL UNKNOWN WERE RETURNED. ENGINEERING ANALYSIS: THE RETURNED 011-MC33564 WAS EVALUATED, THE SET WAS FLUSHED WITH NO ISSUES REPLICATED, NO OBVIOUS VISUAL ABNORMALITIES, DEFECTS AND OR COMPONENT DAMAGES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451805 7" CLAVE EXT. SET 7: CLAVE EXT. SET FPA ICU MEDICAL, INC. 011-MC33564 2962419

    Patients

    Seq Age Sex Outcome Treatment
    1 NI VARIOUS SYRINGE SIZE/TYPE UNK| 3-WAY STOPCOCK